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JP4847149B2 - Near infrared spectrometer with reusable part - Google Patents
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JP4847149B2 - Near infrared spectrometer with reusable part - Google Patents

Near infrared spectrometer with reusable part Download PDF

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JP4847149B2
JP4847149B2 JP2006032696A JP2006032696A JP4847149B2 JP 4847149 B2 JP4847149 B2 JP 4847149B2 JP 2006032696 A JP2006032696 A JP 2006032696A JP 2006032696 A JP2006032696 A JP 2006032696A JP 4847149 B2 JP4847149 B2 JP 4847149B2
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ジー．ハッカー トーマス
ダブリュ．アレン ブレント
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テルモ カーディオバスキュラー システムズ コーポレイション
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14553—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted for cerebral tissue
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/359—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N21/4738—Diffuse reflection, e.g. also for testing fluids, fibrous materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
    • A61B2562/221—Arrangements of sensors with cables or leads, e.g. cable harnesses
    • A61B2562/222—Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
    • A61B2562/221—Arrangements of sensors with cables or leads, e.g. cable harnesses
    • A61B2562/223—Optical cables therefor

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  • Health & Medical Sciences (AREA)
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  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Surgery (AREA)
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Description

本発明は、外科手術中の患者の酸素化関連パラメータの測定に一般的に関し、さらに特に、再使用可能部分と使い捨て部分とを有し、かつ、特に心臓手術中に脳内の血液のヘモグロビンレベルおよび／または酸素搬送能力を監視するようになっている、近赤外分光センサ装置に関する。   The present invention relates generally to the measurement of patient oxygenation-related parameters during surgery, and more particularly has a reusable part and a disposable part, and in particular hemoglobin levels of blood in the brain during cardiac surgery And / or a near-infrared spectroscopic sensor device adapted to monitor oxygen carrying capacity.

心臓手術中は、脳内の酸素化関連パラメータを外科医が監視することが非常に有用である。心臓手術中の神経学的損傷の主な原因は、脳血流量の減少と、不十分な酸素化と、不十分なヘモグロビン濃度と、脳塞栓症とを含む。脳が手術中に低い酸素レベルを被ると、手術後に神経学的な問題が生じる危険性が増大し、こうした神経学的な問題は、救急救命処置の必要性の増大と、より長期の入院との原因となる。脳監視装置の使用が、外科チームの構成員が脳の酸素レベルおよび／ヘモグロビン濃度の変化を監視して脳損傷の発生の前に処置を行うこととを補助する。   During cardiac surgery, it is very useful for the surgeon to monitor oxygenation related parameters in the brain. Major causes of neurological damage during cardiac surgery include decreased cerebral blood flow, insufficient oxygenation, insufficient hemoglobin concentration, and cerebral embolism. If the brain experiences low oxygen levels during surgery, there is an increased risk of neurological problems after surgery, which increases the need for emergency life-saving procedures and longer hospital stays. Cause. The use of brain monitoring devices assists surgical team members to monitor changes in brain oxygen levels and / or hemoglobin concentrations and take action prior to the occurrence of brain injury.

脳を監視する従来の方法の幾つかが侵襲的であり、他の医療上の危険性を生じさせた。近赤外分光測定（ＮＩＲＳ）が、患者の額に取り付けられた発光体とセンサとを使用する、脳を灌流する血液の酸素レベルおよびヘモグロビン濃度を監視する非侵襲的な方法として開発されてきた。公知のシステムは、電流センサが大きくて扱いにくく、および、外部光源によって悪影響を受ける可能性があるので、未解決の問題を有している。このセンサは、さらに、額に取り付けられた状態に留まることが困難である。患者の額に堅固に取り付けられた状態に留まるだけでなく、麻酔を監視するためのＢＩＳ監視装置のような他の監視装置のための余地を患者の額に残す、より小型のセンサが必要とされている。したがって、患者の額に堅固に取り付けられた状態に留まりかつ外部光による悪影響をより受けにくい小型ＮＩＲＳセンサ装置が、当業において依然として必要とされている。   Some of the traditional methods of monitoring the brain have been invasive and have created other medical risks. Near Infrared Spectroscopy (NIRS) has been developed as a non-invasive method of monitoring oxygen levels and hemoglobin concentrations in the blood perfused through the brain using a illuminator and sensor attached to the patient's forehead. . Known systems have unresolved problems because current sensors are large and cumbersome and can be adversely affected by external light sources. This sensor is also difficult to remain attached to the forehead. There is a need for a smaller sensor that not only stays firmly attached to the patient's forehead, but also leaves room for other monitoring devices such as a BIS monitoring device to monitor anesthesia. Has been. Accordingly, there remains a need in the art for a compact NIRS sensor device that remains firmly attached to the patient's forehead and is less susceptible to the adverse effects of external light.

さらに、患者の立場から見て、ＮＩＲＳセンサの安全で衛生的な使用を確実なものにし、かつ、医師の立場から見て、効率と、使用の容易さと、他の手術／監視システムとの組合せの容易さとを改善することが必要とされている。   Furthermore, from the patient's standpoint, ensuring the safe and hygienic use of the NIRS sensor, and from the physician's standpoint, the combination of efficiency, ease of use and other surgical / monitoring systems There is a need to improve the ease of.

本発明は、サイズが小さく、患者に対する確実な取り付けを実現し、周囲光を遮断し、使用が容易であり、衛生的であり、かつ、外科手術システムおよび監視システムとのデータ統合をサポートする、脳の監視のための改良されたＮＩＲＳセンサ装置である。このセンサ装置は、ハイブリッドケーブルを経由して遠隔の近赤外光源に接続される。この光源が遠隔配置されているので、高エネルギーの短パルスを提供するようになっている光源が容易に使用されることが可能であり、その結果として、表在性の非脳組織による干渉を受ける可能性がより低く、かつ、周囲光からの干渉がより少ない。これに加えて、この遠隔配置が、低体温処置中に従来技術において生じる局所光源の出力の変化（例えば、温度低下の結果としてのＬＥＤにおける帯域幅の変化）を回避する。従来技術で典型的に使用される局所的に装着されたＬＥＤとは反対に、より高いエネルギーがレーザダイオードの使用によって実現されてよい。このセンサ装置は、１つまたは複数の光検出器を含む再使用可能部分と、この再使用可能部分から光を受け取り、および、脳の中にその光を方向付けるためにその光を曲げる使い捨て部分とを備える、２つの部分から構成される設計である。この使い捨て部分は、患者の額に付着させられる唯一の部分である。ケーブルが、光導体と導電体との両方を含むハイブリッドタイプであることが好ましく、および、採用随意に光学的かつ電磁的に絶縁されている。この設計によって、１本のケーブルしか必要でないので、そのアセンブリ全体の製造が容易であり、および、エンドユーザにとってその使用がより管理しやすい。   The present invention is small in size, provides secure attachment to a patient, blocks ambient light, is easy to use, is hygienic, and supports data integration with surgical and monitoring systems. An improved NIRS sensor device for brain monitoring. This sensor device is connected to a remote near-infrared light source via a hybrid cable. Because this light source is remotely located, a light source adapted to provide high energy short pulses can be easily used, resulting in interference from superficial non-brain tissue. Less likely to receive and less interference from ambient light. In addition, this remote placement avoids local light source output changes (eg, bandwidth changes in LEDs as a result of temperature drop) that occur in the prior art during hypothermic treatment. In contrast to locally mounted LEDs typically used in the prior art, higher energy may be achieved through the use of laser diodes. The sensor device includes a reusable part including one or more photodetectors and a disposable part that receives light from the reusable part and bends the light to direct the light into the brain Is a design composed of two parts. This disposable part is the only part that is attached to the patient's forehead. The cable is preferably of the hybrid type including both a light guide and a conductor, and is optionally optically and electromagnetically insulated. With this design, only one cable is required, so the entire assembly is easy to manufacture and its use is more manageable for the end user.

本発明の一側面では、近赤外分光システムが、患者の体表下の酸素化関連パラメータを監視する。再使用可能プローブ部分が、遠隔光源から近赤外光を搬送するためのハイブリッドケーブルに取り付けられたフェルール部材を含む。この再使用可能プローブ部分は、さらに、１対の光検出器を含む。そのフェルール部材は、その１対の光検出器から間隔を置いて配置されている末端を有する。使い捨てカプラ部分が、患者の体表に向かって近赤外光を方向付けるための、フェルール部材の末端に選択的に結合されるようになっている光路部材を固定的に装着する可とう性ハウジングを備える。この可とう性ハウジングは、さらに、患者の体表に使い捨てカプラ部分を一時的に取り付けるための接着剤層を備える。この可とう性ハウジングは、使い捨てカプラ部分が再使用可能プローブ部分に着脱自在に連結される時に患者からの反射近赤外光を受け入れるための、１対の赤外検出器と整合した形に配置されている窓を含む。   In one aspect of the invention, a near infrared spectroscopy system monitors oxygenation related parameters under the patient's body surface. The reusable probe portion includes a ferrule member attached to a hybrid cable for carrying near infrared light from a remote light source. The reusable probe portion further includes a pair of photodetectors. The ferrule member has a distal end that is spaced from the pair of photodetectors. A flexible housing in which the disposable coupler portion is fixedly mounted with an optical path member adapted to be selectively coupled to the distal end of the ferrule member for directing near infrared light toward the body surface of the patient Is provided. The flexible housing further includes an adhesive layer for temporarily attaching the disposable coupler portion to the patient's body surface. The flexible housing is aligned with a pair of infrared detectors for receiving reflected near infrared light from the patient when the disposable coupler portion is removably coupled to the reusable probe portion. Including windows.

さて、図１と図２を参照すると、ＮＩＲＳセンサ装置１０が使い捨てカプラ部分１２と再使用可能プローブ部分１４とを備える。再使用可能プローブ部分１４に一体化されているハイブリッド（光学／電気）ケーブル１６が、モニタコントローラ（図示していない）に対する光学および電気接続を実現する。再使用可能プローブ部分１４は、使い捨てカプラ部分１２の受けスロット１８内に着脱自在に挿入されることが可能である。これら２つの部分を一体に保つことを促進するためにこれら２つの部分が嵌合させられる時に、ロッキング要素１５、１７が互いに噛み合う。要素１５は柔軟なゴム製オーバーモールド（ｏｖｅｒｍｏｌｄ）の部分であり、および、要素１７内で容易に圧縮される。さらに、この要素１５は、これら２つの部分の嵌合解除が必要である時に選択的に取り外されることが可能である。   1 and 2, the NIRS sensor device 10 includes a disposable coupler portion 12 and a reusable probe portion 14. A hybrid (optical / electrical) cable 16 integrated into the reusable probe portion 14 provides optical and electrical connections to a monitor controller (not shown). The reusable probe portion 14 can be removably inserted into the receiving slot 18 of the disposable coupler portion 12. When the two parts are mated to help keep the two parts together, the locking elements 15, 17 mesh with each other. Element 15 is part of a flexible rubber overmold and is easily compressed within element 17. Furthermore, this element 15 can be selectively removed when the disengagement of these two parts is necessary.

図３に示すように、インジケータレンズ２１とピン部材２２とを含む光路部材２０が、受けスロット１８と、再使用可能プローブ部分１４の光検出器末端を受け入れる窓２４とを画定するオーバーモールド２３の中に埋め込まれている。レンズ２１は、部分１２、１４の嵌合の後にそのレンズ１２が目に見えるように要素１５内に中央に配置されている。   As shown in FIG. 3, an optical path member 20 including an indicator lens 21 and a pin member 22 defines an overmold 23 that defines a receiving slot 18 and a window 24 that receives the photodetector end of the reusable probe portion 14. Embedded inside. The lens 21 is centrally arranged in the element 15 so that the lens 12 is visible after the fitting of the portions 12, 14.

図４が、患者の額にその装置を取り付けるための接着剤層を含む使い捨てカプラ部分１２の底部の患者接触表面２５を示す。オーバーモールド２３は、額または他の取り付け場所の輪郭に適合することが可能であるように柔軟である。任意の従来通りの生体適合性の接着剤が、当業で公知であるように使用されてよい。光路部材２０は、再使用可能プローブ部分１４からの近赤外光を受け取るための入口カプラ２６と、患者の体表（例えば、皮膚表面）に向かって垂直方向に近赤外光を方向付けるための出口２７とを含む。   FIG. 4 shows the patient contact surface 25 at the bottom of the disposable coupler portion 12 including an adhesive layer for attaching the device to the patient's forehead. The overmold 23 is flexible so that it can adapt to the contours of the forehead or other mounting locations. Any conventional biocompatible adhesive may be used as is known in the art. The optical path member 20 has an inlet coupler 26 for receiving near infrared light from the reusable probe portion 14 and directs near infrared light in a vertical direction toward the patient's body surface (eg, skin surface). Outlet 27.

光路部材２０の底部側が図５により詳細に示されている。この光路３０は入口カプラ２６と出口２７との間を延び、および、ハイブリッドケーブル上の対応するタブを受け入れるためのキーイングスロット３１を有する。フランジ３２が、所定の位置に据え込まれてよい管状ピン部材２２を受け入れるための穴を含む。電子記憶装置３４の接続ピン３３が、外部接続のためのピン部材２２内に（例えば、圧力ばめによって）電気的に装着される。光路部材２０は、さらに、再使用可能プローブ部分１４内の装置から可視光を受け取るための、および、インジケータレンズ２１にその可視光を提供するための光導波路３５を含む。   The bottom side of the optical path member 20 is shown in more detail in FIG. This optical path 30 extends between the inlet coupler 26 and outlet 27 and has a keying slot 31 for receiving a corresponding tab on the hybrid cable. Flange 32 includes a hole for receiving tubular pin member 22 that may be installed in place. The connection pin 33 of the electronic storage device 34 is electrically mounted (for example, by pressure fitting) in the pin member 22 for external connection. The optical path member 20 further includes an optical waveguide 35 for receiving visible light from the device in the reusable probe portion 14 and for providing the visible light to the indicator lens 21.

光路部材２０のわずかに変更された実施形態の上面側斜視図が図６と図７に示されている。この実施形態は、フランジ３２が光路３０の両側から延びるという点で異なる。この図では、可視光を光導波路３５を通過させてインジケータレンズ２１に結合することが見て取れる。レンズ２１の下方の傾斜した反射性表面３６が、ユーザによる容易な視認のために表示光を上向きに方向付けることに役立つ。さらに、傾斜した反射性表面３７が、近赤外光を提供するケーブルが患者の体表に対して平行に位置することを可能にすると同時に、近赤外光が患者に垂直方向に進入するようにその近赤外光を９０度曲げるために、光路３０内に形成されている。図８が、柔軟なゴム製オーバーモールド２３内にカプセル封入された電子記憶装置３４を含む光路部材２０を示す。図９が、そのカプセル封入された部品の断面図を示す。図１０が、カプセル封入の前に、どのように接続ピン３３が管状ピン部材２２の中に圧力ばめされてよいかを示す。   A top perspective view of a slightly modified embodiment of the optical path member 20 is shown in FIGS. This embodiment differs in that the flange 32 extends from both sides of the optical path 30. In this figure, it can be seen that visible light passes through the optical waveguide 35 and is coupled to the indicator lens 21. An inclined reflective surface 36 below the lens 21 helps direct the display light upward for easy viewing by the user. Furthermore, the inclined reflective surface 37 allows the cable providing near infrared light to be positioned parallel to the patient's body surface, while allowing near infrared light to enter the patient in a vertical direction. In order to bend the near-infrared light by 90 degrees, it is formed in the optical path 30. FIG. 8 shows the optical path member 20 including an electronic storage device 34 encapsulated within a flexible rubber overmold 23. FIG. 9 shows a cross-sectional view of the encapsulated part. FIG. 10 shows how the connection pin 33 may be pressure fitted into the tubular pin member 22 prior to encapsulation.

次に、再使用可能プローブ部分１４の好ましい実施形態の詳細な構造に言及すると、図１１が、ハイブリッドケーブル１６の末端付近に装着されているフェルール部材４１に連結されているフレキシブルプリント回路基板４０を示す。光導波路４２が、（例えば、モニタコントローラまたはデバイスベイに配置された）遠隔光源からの近赤外光を配送する。ケーブル１６内の導電体が取り出されて、フェルール部材４１の中を通して、フレキシブル回路基板４０上の複数の接続点４３に配線される。硬質の回路基板４４がフェルール部材４１の端面に取り付けられ、および、さらに、ケーブル１６からの導電体にも接続される。回路基板４４は、電力がケーブル１６を経由して受け取られる時に使い捨てカプラ部分の光路部材内の光導波路３５に可視光を提供するための光発生器４５（好ましくはＬＥＤ）を含む。モニタコントローラ内の回路が電子記憶装置３４と通信することが可能であるように、レセプタクル４６が、その２つの装置部分が嵌合させられる時にピン部材２２を受け入れる。   Referring now to the detailed structure of the preferred embodiment of the reusable probe portion 14, FIG. 11 shows a flexible printed circuit board 40 coupled to a ferrule member 41 mounted near the end of the hybrid cable 16. Show. A light guide 42 delivers near infrared light from a remote light source (eg, located in a monitor controller or device bay). The conductor in the cable 16 is taken out and routed through the ferrule member 41 to a plurality of connection points 43 on the flexible circuit board 40. A rigid circuit board 44 is attached to the end face of the ferrule member 41 and is further connected to a conductor from the cable 16. The circuit board 44 includes a light generator 45 (preferably an LED) for providing visible light to the light guide 35 in the light path member of the disposable coupler portion when power is received via the cable 16. Receptacle 46 receives pin member 22 when the two device portions are mated so that circuitry within the monitor controller can communicate with electronic storage device 34.

フレキシブル回路基板４０は、この回路基板４０が光検出器アセンブリ５３に接続する遠位端部５２に延びる２つの細長い指片部分５０、５１を含む。図１２に分解組立図の形で示されているように、遠位端部５２は、その上に取り付けられているインタフェース回路構成要素を有してもよい。光検出器集積回路素子５５が、例えばはんだ付けによって、遠位の基板端部５２に接続されている。絶縁発泡体部品５６が遠位基板端部５２上の構成要素の上に重なり、および、これらの構成要素をＥＭＩカバーまたはシールド５７から絶縁する。下部キャップ５８と蓋５９とを有するプラスチックハウジングが、光検出器アセンブリ５３を封止するために取り付けられている。   The flexible circuit board 40 includes two elongated finger segments 50, 51 that extend to a distal end 52 where the circuit board 40 connects to the photodetector assembly 53. As shown in an exploded view in FIG. 12, the distal end 52 may have interface circuit components mounted thereon. A photodetector integrated circuit element 55 is connected to the distal substrate end 52, for example by soldering. An insulating foam component 56 overlies the components on the distal substrate end 52 and insulates these components from the EMI cover or shield 57. A plastic housing having a lower cap 58 and a lid 59 is attached to seal the photodetector assembly 53.

図１３から図２１は、再使用可能プローブ部分のための好ましい製造プロセスにおける幾つかの代表的な段階を示す。図１３では、光検出器ユニット５５を含むすべての構成要素がフレキシブル基板４０にはんだ付けされている。図１４では、フェルール部材４１が、導電ワイヤを剥ぐことと光導波管を露出させることとによって用意されたハイブリッドケーブル１６の末端上に取り付けられる。このワイヤは、回路基板に対するはんだ付けのために、フェルール部材４１内の通路の中を通して回路基板に引き回されてもよい。光路部材のキーイングスロット３１と嵌合するためのキーイング要素６０が、フェルール部材４１と一体の形で示されている。フェルール部材４１がケーブル１６上に接着されていることが好ましい。図１５と図１６は、フェルール部材４１に対するフレキシブル基板４０のアセンブリをさらに詳細に示す。ケーブル１６からの導電ワイヤが基板４０内の穴６１にはんだ付けされている。その次に、信号がトレース６２を経由して光検出器アセンブリの中にまたは光検出器アセンブリから外に通されることが可能である。   FIGS. 13-21 illustrate some representative steps in a preferred manufacturing process for a reusable probe portion. In FIG. 13, all the components including the photodetector unit 55 are soldered to the flexible substrate 40. In FIG. 14, a ferrule member 41 is mounted on the end of the hybrid cable 16 prepared by peeling the conductive wire and exposing the optical waveguide. This wire may be routed through the passage in the ferrule member 41 to the circuit board for soldering to the circuit board. A keying element 60 for mating with the keying slot 31 of the optical path member is shown in one piece with the ferrule member 41. The ferrule member 41 is preferably bonded onto the cable 16. 15 and 16 show the assembly of the flexible substrate 40 to the ferrule member 41 in more detail. Conductive wires from the cable 16 are soldered to holes 61 in the substrate 40. The signal can then be passed through the trace 62 into or out of the photodetector assembly.

図１７から図２１に示すように、絶縁体５６が基板４０の遠位端部５２上に配置されている。図１８では、光検出器アセンブリは下部カップ５８の中に挿入されている。図１９に示すように、カップ５８の底部は、公知のＮＩＲＳ検出で使用される１対の光検出器要素の位置に対応する穴６３、６４を含む。再使用可能プローブ部分を水密にするために、光検出器アセンブリの周囲と穴６３、６４の周囲とにおいて、シリコンシーラをカップ５８の中に注入することが好ましい。図２０では、絶縁体とＥＭＩカバーとがカップ５８の中に挿入されている。図２１が、蓋５９がカップ５８に取り付けられた後の光検出器アセンブリを示す。   An insulator 56 is disposed on the distal end 52 of the substrate 40 as shown in FIGS. In FIG. 18, the photodetector assembly is inserted into the lower cup 58. As shown in FIG. 19, the bottom of the cup 58 includes holes 63, 64 corresponding to the position of a pair of photodetector elements used in known NIRS detection. A silicon sealer is preferably injected into the cup 58 around the photodetector assembly and around the holes 63, 64 to make the reusable probe portion watertight. In FIG. 20, the insulator and the EMI cover are inserted into the cup 58. FIG. 21 shows the photodetector assembly after the lid 59 has been attached to the cup 58.

フレキシブル基板４０の中央部分は、回路のトレースを保護しかつ耐久性を実現するために、さらに別のプラスチックハウジングまたはオーバーモールドによって覆われている。   The central portion of the flexible substrate 40 is covered by a further plastic housing or overmold to protect circuit traces and achieve durability.

図２２は、嵌合状態にある２つの部分の底面側斜視図を示す。嵌合後には、光検出器は、使い捨て部分１２内の窓２４と整合している。さらに、穴６３、６４を通して患者からの反射光を受け取る２つの光検出器が、ＮＩＲＳセンサの公知の動作にしたがって、光路３０の出口２７から予め決められた距離に間隔を置いて配置されている。   FIG. 22 shows a bottom perspective view of the two parts in the fitted state. After mating, the photodetector is aligned with the window 24 in the disposable part 12. In addition, two photodetectors that receive the reflected light from the patient through the holes 63, 64 are spaced a predetermined distance from the outlet 27 of the optical path 30 in accordance with the known operation of the NIRS sensor. .

図２３に示すように、ＮＩＲＳ装置１０は、監視中は患者７１の額７０に取り付けられる。異なるタイプの監視のためには、患者の身体の他の区域内の他の皮膚表面に対する取り付けが使用されてよい。装置１０は、センサ７１のような他のパラメータを監視するための他のセンサがさらに額に取り付けられてもよいように、十分にコンパクトである。   As shown in FIG. 23, the NIRS device 10 is attached to the forehead 70 of the patient 71 during monitoring. For different types of monitoring, attachments to other skin surfaces in other areas of the patient's body may be used. The device 10 is sufficiently compact so that other sensors for monitoring other parameters, such as sensor 71, may be further attached to the forehead.

図２４は、プログラム可能な計算要素を含むことが好ましいモニタコントローラまたはデバイスベイ７５に装置１０が接続されている監視システムの全体を示す。モニタ７６が、医師による視認のために、測定された酸素化関連パラメータを表示する。   FIG. 24 shows the overall monitoring system in which the apparatus 10 is connected to a monitor controller or device bay 75 that preferably includes programmable computational elements. A monitor 76 displays the measured oxygenation related parameters for viewing by the physician.

使い捨て部分と嵌合している再使用可能部分を含む、アセンブリが完了したＮＩＲＳセンサの等角図である。FIG. 5 is an isometric view of a completed NIRS sensor including a reusable part mated with a disposable part. 嵌合する前の再使用可能部分と使い捨て部分との等角図である。FIG. 5 is an isometric view of a reusable part and a disposable part before mating. 使い捨て部分の背面側を示す等角図である。It is an isometric view which shows the back side of a disposable part. 使い捨て部分の底部の患者接触面を示す等角図である。FIG. 6 is an isometric view showing a patient contact surface at the bottom of a disposable part. 使い捨て部分の光路部材と電子記憶装置との一実施形態の底面側斜視図である。It is a bottom side perspective view of one embodiment of an optical path member of a disposable part and an electronic storage device. 光路部材の別の実施形態の分解組立斜視図である。It is a disassembled perspective view of another embodiment of an optical path member. 図６の実施形態の分解組立斜視図である。FIG. 7 is an exploded perspective view of the embodiment of FIG. 6. 光路部材上にオーバーモールドされた可とう性ハウジングを示す部分切欠図である。FIG. 6 is a partial cutaway view showing a flexible housing overmolded on an optical path member. 使い捨て部分の断面斜視図である。It is a cross-sectional perspective view of a disposable part. 光路部材のさらに別の図である。It is another figure of an optical path member. オーバーモールドが取り除かれている再使用可能部分の斜視図である。FIG. 5 is a perspective view of a reusable part with the overmold removed. 図１１の再使用可能部分の分解組立斜視図である。FIG. 12 is an exploded perspective view of the reusable part of FIG. 11. 再使用可能部分のフレキシブル回路基板に取り付けられている光検出器の斜視図である。It is a perspective view of the photodetector attached to the flexible circuit board of a reusable part. ハイブリッドケーブルに取り付けられているフェルール部材を示す。The ferrule member attached to the hybrid cable is shown. フレキシブル回路基板とフェルール部材との相互接続を示す。Fig. 4 shows interconnection between a flexible circuit board and a ferrule member. フレキシブル回路基板とフェルール部材との相互接続を示す。Fig. 4 shows interconnection between a flexible circuit board and a ferrule member. ＥＭＩシールドと、光検出器とを収容するためのプラスチックハウジングとを示す。Figure 3 shows an EMI shield and a plastic housing for housing the photodetector. ＥＭＩシールドと、光検出器とを収容するためのプラスチックハウジングとを示す。Figure 3 shows an EMI shield and a plastic housing for housing the photodetector. ＥＭＩシールドと、光検出器とを収容するためのプラスチックハウジングとを示す。Figure 3 shows an EMI shield and a plastic housing for housing the photodetector. ＥＭＩシールドと、光検出器とを収容するためのプラスチックハウジングとを示す。Figure 3 shows an EMI shield and a plastic housing for housing the photodetector. ＥＭＩシールドと、光検出器とを収容するためのプラスチックハウジングとを示す。Figure 3 shows an EMI shield and a plastic housing for housing the photodetector. アセンブリされたＮＩＲＳセンサ装置の底面側等角図である。FIG. 6 is a bottom isometric view of the assembled NIRS sensor device. 患者に取り付けられている１対のＮＩＲＳセンサを示す。Fig. 2 shows a pair of NIRS sensors attached to a patient. モニタコントローラを含む監視システムを示す。1 shows a monitoring system including a monitor controller.

符号の説明Explanation of symbols

１０ ＮＩＲＳセンサ装置
１２ 使い捨てカプラ部分
１４ 再使用可能プローブ部分
１５ ロッキング要素
１６ ハイブリッドケーブル
１７ ロッキング要素
１８ 受けスロット
２０ 光路部材
２１ インジケータレンズ
２２ ピン部材
２３ オーバーモールド
２４ 窓
２５ 患者接触表面
２６ 入口カプラ
２７ 出口 DESCRIPTION OF SYMBOLS 10 NIRS sensor apparatus 12 Disposable coupler part 14 Reusable probe part 15 Locking element 16 Hybrid cable 17 Locking element 18 Receiving slot 20 Optical path member 21 Indicator lens 22 Pin member 23 Overmold 24 Window 25 Patient contact surface 26 Inlet coupler 27 Outlet

Claims (13)

患者の体表下の酸素化関連パラメータを監視する近赤外分光システムであって、
遠隔光源から近赤外光を搬送するためのハイブリッドケーブルに取り付けられているフェルール部材を含む再使用可能プローブ部分であって、１対の光検出器をさらに備え、および、前記フェルール部材は前記１対の光検出器から間隔を置いて配置された末端を有する再使用可能プローブ部分と、
前記再使用可能なプローブ部分が着脱自在に挿入される受けスロットを備えた可とう性ハウジングを備える使い捨てカプラ部分であって、前記使い捨てカプラ部分が、さらに、前記体表に向けて前記近赤外光を方向付けるために、前記フェルール部材の前記末端に選択的に結合されるようになっている光路部材を備えていて、前記可とう性ハウジングは、さらに、前記体表に前記使い捨てカプラ部分を一時的に取り付けるための接着剤層を備え、前記可とう性ハウジングは、前記使い捨てカプラ部分が前記再使用可能プローブ部分に着脱自在に連結される時に、前記患者からの反射近赤外光を受け入れるための、前記１対の赤外検出器と整合した形に配置されている窓を含んでおり、従がって、前記使い捨てカプラ部分だけが前記体表に接着される使い捨てカプラ部分と、
を備えるシステム。 A near-infrared spectroscopy system for monitoring oxygenation-related parameters under a patient's body surface,
A reusable probe portion including a ferrule member attached to a hybrid cable for carrying near infrared light from a remote light source, further comprising a pair of photodetectors, wherein the ferrule member is A reusable probe portion having ends spaced from the pair of photodetectors;
A disposable coupler part comprising a flexible housing with a receiving slot into which the reusable probe part is detachably inserted, wherein the disposable coupler part is further towards the body surface to direct the light, the Te Tei with an optical path member adapted to be selectively coupled to the end of the ferrule member, the flexible housing further said disposable coupler portion to the body surface An adhesive layer for temporary attachment, wherein the flexible housing receives reflected near infrared light from the patient when the disposable coupler portion is removably coupled to the reusable probe portion; for, bonding the pair of infrared detector and window disposed in aligned form and Nde including, slave is I, the only the body surface the disposable coupler portion And disposable coupler portion that is,
A system comprising: 前記光路部材は、前記体表に対して実質的に垂直な方向に前記近赤外光を方向付けるための反射性表面を備える請求項１に記載のシステム。 The optical path member A system according to claim 1 to obtain Bei a reflective surface for directing the near infrared light in a direction substantially perpendicular to the body surface. 前記可とう性ハウジングは、柔軟なゴムを含む実質的に不透明なオーバーモールドを備える請求項２に記載のシステム。   The system of claim 2, wherein the flexible housing comprises a substantially opaque overmold comprising a flexible rubber. 前記再使用可能プローブ部分は、The reusable probe portion is
第１の端部において前記フェルール部材に取り付けられておりかつ第２の端部において前記１対の光検出器に接続されている細長いフレキシブルプリント回路基板であって、前記ハイブリッドケーブルに前記光検出器を相互接続するために導電トレースを含むフレキシブルプリント回路基板An elongated flexible printed circuit board attached to the ferrule member at a first end and connected to the pair of photodetectors at a second end, wherein the photodetector is connected to the hybrid cable Flexible printed circuit board including conductive traces for interconnecting
をさらに備える請求項１に記載のシステム。The system of claim 1, further comprising: 前記第２の端部に取り付けられているＥＭＩカバーと、An EMI cover attached to the second end;
前記光検出器と前記ＥＭＩカバーとを収容する硬質のハウジングと、A rigid housing that houses the photodetector and the EMI cover;
前記フレキシブル回路基板を覆うオーバーモールド本体と、An overmold body covering the flexible circuit board;
をさらに備える請求項４に記載のシステム。The system of claim 4 further comprising: 前記再使用可能プローブ部分の前記オーバーモールド本体と、前記使い捨てカプラ部分の前記可とう性ハウジングは、前記使い捨てカプラ部分と前記再使用可能プローブ部分とが使用のために連結される時に、前記使い捨てカプラ部分と前記再使用可能プローブ部分を確実に保持するためのそれぞれのロッキング要素を含む請求項５に記載のシステム。The overmold body of the reusable probe portion and the flexible housing of the disposable coupler portion are configured such that when the disposable coupler portion and the reusable probe portion are coupled for use, the disposable coupler 6. The system of claim 5, including a respective locking element for securely holding a portion and the reusable probe portion. 前記光検出器は、使用のために連結される時に前記光路部材から予め決められた距離にそれぞれに間隔を置いて位置している請求項６に記載のシステム。The system of claim 6, wherein the photodetectors are each spaced a predetermined distance from the optical path member when coupled for use. 近赤外分光法を使用する脳監視システムのための、再使用可能部分と使い捨て部分とを具備するセンサ装置であって、A sensor device comprising a reusable part and a disposable part for a brain monitoring system using near infrared spectroscopy, comprising:
前記再使用可能部分は、近赤外光源に連結するためのフェルール部材と、フレキシブル回路基板と、前記フェルール部材とは反対側に位置した遠位端部において前記フレキシブル回路基板に取り付けられている光検出器と、前記光検出器の一部分の周りに配置されているＥＭＩシールドと、少なくとも前記フレキシブル回路基板を覆うオーバーモールドとを備え、および、The reusable part includes a ferrule member for coupling to a near-infrared light source, a flexible circuit board, and light attached to the flexible circuit board at a distal end located on the opposite side of the ferrule member. A detector, an EMI shield disposed around a portion of the photodetector, an overmold covering at least the flexible circuit board, and
前記使い捨て部分は、光曲げ光路と、前記フレキシブル回路基板に対してインタフェースするための電子接続ピンと、患者接触接着剤層、及び前記再使用可能なプローブ部分が着脱自在に挿入される受けスロットを有する可とう性ハウジングオーバーモールドとを備えており、従って、前記使い捨てカプラ部分だけが前記体表に接着される、The disposable part has a light bending optical path, an electronic connection pin for interfacing with the flexible circuit board, a patient contact adhesive layer, and a receiving slot into which the reusable probe part is detachably inserted. A flexible housing overmold, so that only the disposable coupler part is adhered to the body surface,
センサ装置。Sensor device. 前記可とう性ハウジングオーバーモールドは、前記光検出器に周囲光が入ることを阻止するためにほぼ不透明である請求項８に記載のセンサ装置。9. The sensor device of claim 8, wherein the flexible housing overmold is substantially opaque to prevent ambient light from entering the photodetector. 前記再使用可能部分は、さらに、遠隔光源から近赤外光を搬送するための、かつ、前記センサ装置をモニタコントローラに電気的に接続するためのハイブリッドケーブルを備える請求項８に記載のセンサ装置。9. The sensor device according to claim 8, wherein the reusable part further comprises a hybrid cable for carrying near-infrared light from a remote light source and for electrically connecting the sensor device to a monitor controller. . 患者の体表下の酸素化関連パラメータを監視する近赤外分光システムであって、A near-infrared spectroscopy system for monitoring oxygenation-related parameters under a patient's body surface,
遠隔光源から近赤外光を搬送するためのハイブリッドケーブルに取り付けられているフェルール部材を含む再使用可能プローブ部分であって、１対の光検出器をさらに備え、および、前記フェルール部材は前記１対の光検出器から間隔を置いて配置された末端を有する再使用可能プローブ部分と、A reusable probe portion including a ferrule member attached to a hybrid cable for carrying near infrared light from a remote light source, further comprising a pair of photodetectors, wherein the ferrule member is A reusable probe portion having ends spaced from the pair of photodetectors;
前記再使用可能なプローブ部分が着脱自在に挿入される受けスロットを備えた可とう性ハウジングを備える使い捨てカプラ部分であって、前記使い捨てカプラ部分が、さらに、前記体表に向けて前記近赤外光を方向付けるために、前記フェルール部材の前記末端に選択的に結合されるようになっている光路部材を備えていて、前記可とう性ハウジングは、さらに、前記体表に前記使い捨てカプラ部分を一時的に取り付けるための接着剤層を備え、前記可とう性ハウジングは、前記使い捨てカプラ部分が前記再使用可能プローブ部分に着脱自在に連結される時に、前記患者からの反射近赤外光を受け入れるための、前記１対の赤外検出器と整合した形に配置されている窓を含んでいる使い捨てカプラ部分とを備えているシステムにおいて、A disposable coupler part comprising a flexible housing with a receiving slot into which the reusable probe part is detachably inserted, wherein the disposable coupler part is further towards the body surface An optical path member adapted to be selectively coupled to the distal end of the ferrule member for directing light, the flexible housing further comprising the disposable coupler portion on the body surface; An adhesive layer for temporary attachment, wherein the flexible housing receives reflected near infrared light from the patient when the disposable coupler portion is removably coupled to the reusable probe portion; And a disposable coupler portion including a window disposed in alignment with the pair of infrared detectors,
前記使い捨てカプラ部分が、さらに、電子記憶装置を備えていて、前記近赤外分光システムがハイブリッドケーブルを経由してモニタコントローラに着脱自在に接続されており、そして前記再使用可能なプローブ部分は、The disposable coupler part further comprises an electronic storage device, the near infrared spectroscopy system is detachably connected to a monitor controller via a hybrid cable, and the reusable probe part comprises:
前記ハイブリッドケーブルを経由して前記電子記憶装置と前記モニタコントローラとの間で情報を伝達するために、前記電子記憶装置と接続するためのデータ回路を含んでいる、Including a data circuit for connecting to the electronic storage device to transmit information between the electronic storage device and the monitor controller via the hybrid cable;
システム。system. 前記電子記憶装置は、接続ピンを有する集積回路を備え、および、前記使い捨てカプラ部分は、さらに、一方の端部において前記接続ピンを受け入れるための、かつ、他方の端部において前記ハイブリッドケーブルと接合するように前記使い捨てカプラ部分から突き出すための、前記光路部材に取り付けられているピン部材を備える請求項１１に記載のシステム。The electronic storage device includes an integrated circuit having a connection pin, and the disposable coupler portion is further adapted to receive the connection pin at one end and to join the hybrid cable at the other end. The system of claim 11, further comprising a pin member attached to the optical path member for protruding from the disposable coupler portion. 患者の体表下の酸素化関連パラメータを監視する近赤外分光システムであって、A near-infrared spectroscopy system for monitoring oxygenation-related parameters under a patient's body surface,
遠隔光源から近赤外光を搬送するためのハイブリッドケーブルに取り付けられているフェルール部材を含む再使用可能プローブ部分であって、１対の光検出器をさらに備え、および、前記フェルール部材は前記１対の光検出器から間隔を置いて配置された末端を有する再使用可能プローブ部分と、A reusable probe portion including a ferrule member attached to a hybrid cable for carrying near infrared light from a remote light source, further comprising a pair of photodetectors, wherein the ferrule member is A reusable probe portion having ends spaced from the pair of photodetectors;
前記再使用可能なプローブ部分が着脱自在に挿入される受けスロットを備えた可とう性ハウジングを備える使い捨てカプラ部分であって、前記使い捨てカプラ部分が、さらに、前記体表に向けて前記近赤外光を方向付けるために、前記フェルール部材の前記末端に選択的に結合されるようになっている光路部材を備えていて、前記可とう性ハウジングは、さらに、前記体表に前記使い捨てカプラ部分を一時的に取り付けるための接着剤層を備え、前記可とう性ハウジングは、前記使い捨てカプラ部分が前記再使用可能プローブ部分に着脱自在に連結される時に、前記患者からの反射近赤外光を受け入れるための、前記１対の赤外検出器と整合した形に配置されている窓を含んでいる使い捨てカプラ部分とを備えているシステムにおいて、A disposable coupler part comprising a flexible housing with a receiving slot into which the reusable probe part is detachably inserted, wherein the disposable coupler part is further towards the body surface An optical path member adapted to be selectively coupled to the distal end of the ferrule member for directing light, the flexible housing further comprising the disposable coupler portion on the body surface; An adhesive layer for temporary attachment, wherein the flexible housing receives reflected near infrared light from the patient when the disposable coupler portion is removably coupled to the reusable probe portion; And a disposable coupler portion including a window disposed in alignment with the pair of infrared detectors,
前記再使用可能なプローブ部分は、さらに、前記フェルール部材に取り付けられた光発生器を備えていて、前記光発生器は、前記ハイブリッドケーブルから電力を受電すると可視光を発生するためのものであり、The reusable probe portion further comprises a light generator attached to the ferrule member, wherein the light generator is for generating visible light upon receiving power from the hybrid cable. ,
前記使い捨てカプラ部分が、さらに、レンズを備えていて、前記レンズは、前記電力を受電したことを表示するために前記可視光を受け、そして前記使い捨てカプラ部分の外側に前記可視光を放射する、The disposable coupler portion further comprises a lens that receives the visible light to indicate that it has received the power and emits the visible light outside the disposable coupler portion;
システム。system.
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US20060189860A1 (en) 2006-08-24

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